USOLDEC 0.15% Eye drops, solution

Зміст інструкції

1. USOLDEC 0,15% Eye drops, solution
   1. What is USOLDEC and what is it used for
   2. What you need to know before you take USOLDEC
   3. How to take USOLDEC
   4. Possible side effects
   5. How to store USOLDEC
   6. Contents of the pack and other information

USOLDEC 0,15% Eye drops, solution

Desametasone sodium phosphate
Equivalent medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What USOLDEC is and what it is used for
• 2. What you need to know before you take USOLDEC
• 3. How to take USOLDEC
• 4. Possible side effects
• 5. How to store USOLDEC
• 6. Contents of the pack and other information

1. What is USOLDEC and what is it used for

USOLDEC contains the active ingredient desamethasone, a corticosteroid, with anti-inflammatory activity.
USOLDEC is used for the treatment of inflammation of some parts of the eye (conjunctiva, eyelid,
cornea, sclera, uvea), also due to allergies (spring conjunctivitis, allergic conjunctivitis, blepharitis and
allergic blepharoconjunctivitis, allergic keratoconjunctivitis, scleritis and episcleritis, uveitis).

2. What you need to know before you take USOLDEC

Do not take USOLDEC

• if you are allergic to desamethasone or to any of the other ingredients of this medicine (listed in section 6);
• if you have high pressure inside your eye (intraocular hypertension);
• if you have eye infections caused by the Herpes simplexvirus;
• if you have corneal infections in an acute ulcerative stage caused by viruses;
• if you have inflammation of the conjunctiva (conjunctivitis) and cornea with lesions (ulcerative keratitis) even in the early stages (positive fluorescein test);
• if you have tuberculosis and eye infection caused by fungi (mycosis);
• if you have eye infections with pus (acute purulent ophthalmia, purulent conjunctivitis, purulent blepharitis and herpetic blepharitis);
• if you have an infection of the eyelid characterized by a swelling similar to a pimple or abscess (hordeolum);
• if you have lesions or abrasions to the cornea;
• if you are a child under three years of age;
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking USOLDEC.
Prolonged use of corticosteroids can cause an increase in pressure inside the eye.
If you use USOLDEC for more than two weeks, your doctor may prescribe a clinical examination to check
the pressure inside the eye (intraocular).
Do not use USOLDEC for long periods, as the use of corticosteroids promotes the development of cataracts (a
condition in which the lens becomes cloudy), which can also become irreversible in the presence of infections
caused by viruses (see "Do not take USOLDEC").
Your doctor will prescribe USOLDEC with great caution if you suffer from diseases accompanied by thinning
of the cornea.
If you suffer from corneal inflammation caused by Herpes viruses (herpetic keratitis), USOLDEC will be
prescribed to you only under strict control of the ophthalmologist.
The administration of USOLDEC in the presence of conjunctivitis (inflammation of the conjunctiva), caused by
bacteria, viruses or fungi can mask the signs of worsening infection.
The use of USOLDEC in the presence of lesions delays healing, promoting the onset and spread of any
infections.
See your doctor if you feel swelling and weight gain around the trunk and face as these are usually the first
manifestations of a syndrome called Cushing's syndrome. Suppression of
the function of the adrenal glands can develop after discontinuation of prolonged or intensive
treatment with USOLDEC. See your doctor before stopping treatment on your own. These risks are important
especially in children and patients treated with a medicine called ritonavir or cobicistat.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
USOLDEC is contraindicated in children under 3 years of age.
If your child is between 3 and 12 years of age, your doctor may prescribe USOLDEC only if it is
strictly necessary and under direct control.

Other medicines and USOLDEC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
ophthalmic products or other medicines, including over-the-counter medicines.
See your doctor if you are using ritonavir or cobicistat, because they can increase the level of desamethasone in
the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
If you are pregnant, your doctor will prescribe USOLDEC only if it is strictly necessary and under direct control.

Driving and operating machinery
USOLDEC does not affect the ability to drive vehicles or operate machinery.
As with any eye medicine, if you experience transient blurred vision during use, wait
until your vision returns to normal before driving or operating machinery.

USOLDEC multi-dose bottle contains benzalkonium chloride
This medicine contains 0.04 mg of benzalkonium chloride per dose, equivalent to four eye drops.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to a change in their
color. Remove contact lenses before application and wait at least 15 minutes before re-applying them.
Benzalkonium chloride can also cause irritation to the eyes, especially if you have dry eyes or corneal disorders (the most superficial transparent layer of the eye). If you feel an abnormal sensation in your eye, burning
or pain after using this medicine, talk to your doctor.

USOLDEC contains phosphate buffer
This medicine contains 0.2 mg of phosphate buffer per drop, equivalent to 3.93 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates can cause, in rare
cases, opaque spots on the cornea due to calcium deposits during treatment.

3. How to take USOLDEC

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The recommended dose is: one drop of eye drops, solution to be instilled into the conjunctival fornix three to four times
a day or as prescribed by your doctor.

Use in children and adolescents
USOLDEC should be administered to children from 3 to 12 years of age only when necessary and under direct
medical supervision.

Instructions for use
Eye drops, solution in a multi-dose bottle:

• 1) Remove the cap (stopper) from the bottle with a slight rotation.
• 2) If using contact lenses, these must be removed before instilling the eye drops and can be reinserted after 15 minutes.
• 3) Turn the bottle upside down and instill by pressing; avoid contact between the container's tip and the eye or other surfaces.
• 4) Screw the cap back on tightly.

Eye drops, solution in single-dose containers:

• 1. Make sure the single-dose vial is intact.
• 2. Detach the single-dose vial from the strip.
• 3. Open by rotating the tab until the container is opened.
• 4. Turn the vial upside down and instill by pressing.
• 5. Position the tip of the vial close to the eye without touching it.
• 6. Dispose of the vial and any remaining contents.

If you take more USOLDEC than you should
In case of overdose, temporarily and gradually discontinue the use of USOLDEC to avoid
irritation, injury or a sudden increase in intraocular pressure (acute glaucoma). Contact your
doctor or pharmacist immediately.
If you accidentally ingest the product, immediately inform your doctor or go to the nearest hospital,
drink fluids to dilute it.

If you forget to take USOLDEC
Do not take a double dose to make up for a missed dose.

If you stop taking USOLDEC
Do not stop treatment without consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of USOLDEC:
Concerning the organism:
allergic reactions (hypersensitivity)
The following side effects have occurred with medicines belonging to the same group of medicines as
USOLDEC (corticosteroids):
Concerning the eye:

• opacity of the lens that alters vision (subcapsular cataract)
• eye infection (including bacterial, fungal and viral infections)
• eye irritation
• perforation of the eye (scleral or corneal perforation)
• increased pressure in the eye
• eye disease due to increased pressure inside the eye (glaucoma)
• burning sensation in the eye
• blurred vision (frequency not known).

In very rare cases, some patients with severe damage to the clear layer in the front of the eye (cornea) have
developed opaque spots on the cornea due to calcium accumulation during treatment.
Unknown side effects (frequency cannot be estimated based on available data):
Hormonal problems: increased hair growth on the body (especially in women), weakness and muscle atrophy,
stretch marks on the skin of the body, increased blood pressure, irregular or
absent menstrual cycle, changes in protein and calcium levels in the body, delayed growth in children and adolescents and
swelling and weight gain of the body and face (called “Cushing’s syndrome”) (see paragraph 2,
“Warnings and precautions”).
In all these cases, the doctor will discontinue the treatment and prescribe appropriate therapy.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store USOLDEC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the last day of that month.
Do not store the medicine at a temperature above 25 °C.

Eye drops - Multidose bottle
The eye drops in a multidose bottle must be used within 28 days of first opening the bottle; after this period, any remaining medicine must be discarded.

Eye drops - Single-dose containers
The eye drops in single-dose containers must be used immediately after opening the container; any remaining medicine must be discarded.
After opening the aluminium sachet, the containers must be used within 28 days: after this period, any remaining containers must be discarded.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What USOLDEC contains
USOLDEC 0.15% Eye drops, solution in a multi-dose bottle
1 ml of solution:

• the active ingredient is: desamethasone sodium phosphate 1.5 mg;
• the other ingredients are: Tribasic sodium citrate dihydrate, Sodium phosphate monobasic dihydrate, Disodium phosphate dihydrate, benzalkonium chloride, water for injections.

USOLDEC 0.15% Eye drops, solution in a single-dose container
1 ml of solution:

• the active ingredient is: desamethasone sodium phosphate 1.5 mg;
• the other ingredients are: Tribasic sodium citrate dihydrate, Sodium phosphate monobasic dihydrate, Disodium phosphate dihydrate, water for injections.

Description of the appearance of USOLDEC and contents of the pack
Eye drops, solution.
Pack containing a 5 ml bottle.
Pack containing 20 single-dose containers of 0.3 ml; each strip of 5 containers is packaged in an aluminum
sachet.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Bionativa S.p.A.
Via Raffaello 15
Loc. Sambuca V.P.
50028 Florence
Italy

Manufacturer
Genetic S.p.A. – Contrada Canfora - Fisciano (SA)

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